Driven by the growing practical need to accelerate drug development and the continuous innovation of trial design in recent years， the number of protocol amendments during clinical trials have gradually increased， and the changed contents have become more flexible and complex， which significantly heightens the difficulty of ethical review on amendments. Against this backdrop， it is of great importance to fully leverage the role and responsibilities of ethics committees， effectively control clinical trial risks， and ensure subject safety. This paper analyzed development trends of protocol amendments in recent years， sorted out requirements for protocol amendments in Chinese regulations and guiding principles， and examined difficulties of amendment ethical review in practical work. Based on these， targeted strategies and recommendations were proposed， namely， strengthening the integration with scientific review， enhancing the formal review， adjusting the scope of review according to approval notifications， and adopting appropriate review methods， with a view to providing insights and references for the management of the amendment ethical review in drug clinical trials.

Objective:To investigate the clinical characteristics and prognosis of acute pancreatitis (AP) with different etiologies.Methods:The retrospective cohort study was conducted. The clinical data of 702 patients with AP who were admitted to Xuanwu Hospital of Capital Medical University from January 2018 to December 2022 were collected. There were 451 males and 251 females,aged (52±17)years. Observation indicators: (1) clinical characteristics of AP patients with different etiologies; (2) complications and prognosis of AP patients with different etiologies; (3) complications and prognosis of moderately severe and severe AP patients with different etiologies. Comparison of measurement data with normal distribution among multiple groups was conducted using the one-way analysis of variance. Comparison of measurement data with skewed distribution among multiple groups was conducted using the Kruskal-Wallis H test. Comparison of count data among multiple groups was conducted using the chi-square test. Results:(1) Clinical characteris-tics of AP patients with different etiologies. Of the 702 AP patients, 434 cases were biliary AP, 199 cases were hypertriglyceridemic-induced AP,29 cases were alcoholic AP, and 40 cases were idiopathic AP. There were significant differences in gender,age,body mass index,combined cardiovascular disease,combined diabetes,combined nephrosis,disease severity and modified computed tomography severity index among AP patients with different etiologies ( χ2=24.61, F=48.65, 12.24, χ2=13.67, 12.90, 14.12, 15.56, H=17.62, P<0.05). (2) Complications and prognosis of AP patients with different etiologies. There was no significant difference in infectious pancreatic necrosis,duration of intensive care unit stay,total duration of hospital stay, and death of patients during hospitalization among AP patients with different etiologies ( P>0.05). (3) Complications and prognosis of moderately severe and severe AP patients with different etiologies. Of the 395 patients with moderately severe and severe AP, 217 cases were biliary AP, 128 cases were hypertriglyceridemic-induced AP, 19 cases were alcoholic AP, and 31 cases were idiopathic AP. There were significant differences in renal injury, multiple organ dysfunction syndrome and walled-off necrosis among moderately severe and severe AP patients with different etiologies ( χ2=12.62, 8.25, 14.33, P<0.05), and there was no significant difference in infectious pancreatic necrosis, lung injury, circulation system injury, duration of intensive care unit stay, total duration of hospital stay, or death of patients during hospitalization among moderately severe and severe AP patients with different etiologies ( P>0.05). Conclusions:The clinical charac-teristics vary among AP patients with different etiologies. The risk of complications varies among moderately severe and severe AP patients with different etiologies.

Objective To explore the effects of transverse cervical artery related skin flaps in repairing skin soft tissue defects in the neck and shoulder.Methods A total of 13 patients with soft tissue defects in neck and shoulder admitted to Linyi People's Hospital from January 2018 to January 2022 were selected.The wounds of patients were repaired with transverse cervical artery related skin flaps,and the donor area was repaired with direct suturing and/or full-thick skin graft from the inguinal area.The survival,appearance and texture of the flap after surgery were recorded.The wound healing in the donor area and the survival of the grafted skin were observed.The follow-up was conducted for 5 to 12 months,and the appearance of the grafted flap and the recovery of function in the surgical area were observed.Results The flaps had good survival in the first stage after surgery,the color and texture of the flap matched well with the surrounding tissue,and the wound healing in the donor area was good.During the follow-up,the function and appearance of neck and shoulder for patients recovered well.Conclusion The advantages of transverse cervical artery related skin flaps in repairing skin soft tissue defects in the neck and shoulder is that the color and texture of the flap matched well with the surrounding tissue,with reliable blood circulation,and the appearance and postoperative function recover well,which is worthy of promotion and application in clinic.

Creutzfeldt-Jakob disease(CJD)is a rapidly progressive and fatal neurodegenerative disorder caused by prions,with certain infectivity and iatrogenic transmission risks.With the rapid progress and application of new dia-gnostic biomarkers and detection methods,as well as the construction and improvement of surveillance and reporting systems,the detection of CJD in patients domestically and internationally has shown an increasing trend year by year.Due to its long incubation period and heterogeneity of early symptoms,early identification and diagnosis of the disease is difficult,increasing the risk of transmission within medical institutions.Currently,there is a lack of con-sensus on the infection prevention and control of CJD.In order to timely identify and diagnose CJD as well as effec-tively block its transmission in medical institutions,this consensus summarizes 15 clinical concerns and formulates 24 specific recommendations based on the latest domestic and international research findings and clinical evidence,as well as combines with clinical practice,aiming to standardize healthcare-associated infection prevention and control measures for CJD and reduce its transmission risk in medical institutions.

Objective:To investigate the association between blood selenium levels and sex hormones in Chinese men aged 18-79 years.Methods:Data were derived from the China National Human Biomonitoring survey conducted in 2017-2018, with a final sample size of 5 414 men. General demographic characteristics, behavioral habits, and dietary frequency were collected through questionnaires and physical examinations. Fasting blood samples were collected to measure blood lead, serum testosterone, and estradiol levels. Complex sampling linear regression models were used to analyze the associations between blood selenium levels and testosterone, estradiol, and the testosterone/estradiol ratio, adjusting for confounding factors including age, education level, marital status, smoking status, alcohol consumption, seafood intake, soy product intake, protein supplement intake, BMI, and diabetes status.Results:The mean age of the 5 414 participants was (46.85±27.91) years; 4 774 (91.65%) were of Han ethnicity and 4 505 (86.68%) were married. The median ( Q1, Q3) blood selenium concentration in men was 97.80 (80.64, 116.99) μg/L. After adjusting for confounding factors, the complex sampling linear regression model revealed negative associations between blood selenium levels and both testosterone levels and the testosterone/estradiol ratio, with a significant linear trend ( Ptrend<0.05). Compared with the Q1 group, the β (95% CI) values for testosterone in the Q2, Q3, and Q4 groups were -0.02 (-0.06 to 0.02), -0.03 (-0.08 to 0.01), and -0.06 (-0.09 to -0.02), respectively. Similarly, the β (95% CI) values for the testosterone/estradiol ratio in the Q2, Q3, and Q4 groups were -0.01 (-0.03 to 0.02), -0.01 (-0.04 to 0.04), and -0.03 (-0.06 to -0.01), respectively. Subgroup analysis indicated stronger associations between blood selenium levels and testosterone/estradiol levels in non-smoking and obese men (BMI≥28 kg/m2). Conclusion:Blood selenium levels are negatively associated with testosterone levels and the testosterone/estradiol ratio in Chinese adult males.

Objective:To explore the association of blood and urinary cadmium levels with lipid profile levels and dyslipidemia in Chinese adults aged 18 to 79 years.Methods:Based on the China National Human Biomonitoring (CNHBM) program, a cross-sectional survey was conducted from 2017 to 2018 using a multi-stage stratified random sampling method, including a total of 10 713 adults aged 18 to 79 years. Data was obtained through questionnaires, physical examinations, biological sample collection, and laboratory testing. Multiple linear mixed effect model (MLMM) and generalized linear mixed effect model (GLMM) were used to analyze the association of blood and creatinine-corrected urinary cadmium levels with lipid profile levels as well as dyslipidemia among adults.Results:The age of 10 713 participants was (47.23±0.24) years, with 5 372 males accounting for 61.3% of the national population. The weighted mean±standard error (SE) of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) was (5.21±0.03), (1.86±0.03), (2.96±0.03), and (1.43±0.01) mmol/L, respectively. The prevalence rate of hypercholesterolemia, hypertriglyceridemia, mixed hyperlipidemia, low HDL-C, and high LDL-C was 16.0%, 21.6%, 6.6%, 13.5%, and 10.0%, respectively. MLMM showed that, after adjusting for relevant confounders, log-transformed blood cadmium levels were positively associated with increased levels of TC, TG and LDL-C ( P<0.05). When blood cadmium levels were categorized into quartiles, compared to the lowest exposure group ( Q1), participants in the highest blood cadmium exposure group ( Q4) had increases of 0.19 (95% CI: 0.06, 0.32) mmol/L in TC and 0.25 (95% CI: 0.08, 0.43) mmol/L in TG. GLMM indicated that, after adjusting for confounders, higher blood cadmium exposure levels were associated with increased risks of hypercholesterolemia, hypertriglyceridemia, mixed hyperlipidemia, and high LDL-C ( P<0.05). Further analysis by quartiles showed that, compared to the blood cadmium Q1 exposure group, the OR value (95% CI) for the Q4 group was 1.53 (1.12, 2.08) for hypercholesterolemia, 1.54 (1.09, 2.17) for hypertriglyceridemia, 2.24 (1.47, 3.40) for mixed hyperlipidemia, and 1.49 (1.07, 2.09) for high LDL-C. Conclusion:The cadmium internal exposure levels are associated with blood lipid profile levels as well as the incidence of dyslipidemia in Chinese adults aged 18 to 79.

Creutzfeldt-Jakob disease(CJD)is a rapidly progressive and fatal neurodegenerative disorder caused by prions,with certain infectivity and iatrogenic transmission risks.With the rapid progress and application of new dia-gnostic biomarkers and detection methods,as well as the construction and improvement of surveillance and reporting systems,the detection of CJD in patients domestically and internationally has shown an increasing trend year by year.Due to its long incubation period and heterogeneity of early symptoms,early identification and diagnosis of the disease is difficult,increasing the risk of transmission within medical institutions.Currently,there is a lack of con-sensus on the infection prevention and control of CJD.In order to timely identify and diagnose CJD as well as effec-tively block its transmission in medical institutions,this consensus summarizes 15 clinical concerns and formulates 24 specific recommendations based on the latest domestic and international research findings and clinical evidence,as well as combines with clinical practice,aiming to standardize healthcare-associated infection prevention and control measures for CJD and reduce its transmission risk in medical institutions.

Objective:To explore the current status of presenteeism among ICU nurses and its correlation with resilience-related practice environment.Methods:Convenience sampling was adopted to select 434 ICU nurses from Beijing Tiantan Hospital, Capital Medical University in October 2022 as study subjects. An online questionnaire was conducted using the General Information Questionnaire, Chinese version of the Standford Presenteeism Scale-6 (SPS-6), and Nurse Resilience-related Practice Environment Factor Assessment Scale. Pearson correlation and multiple linear regression analysis were used to explore the relationship between ICU nurses' resilience-related practice environment and presenteeism.Results:Among ICU nurses, the total score on the Nurse Resilience-related Practice Environment Factor Assessment Scale was (122.71±26.14) and the SPS-6 score was (16.11±4.66). Presenteeism was negatively correlated with total scores on the Nurse Resilience-related Practice Environment Factor Assessment Scale and scores on career support and development, practice support and development, and personal support and development ( r=-0.494, -0.471, -0.444, and -0.476; P<0.001). Regression analysis showed that resilience-related practice environment negatively predicted presenteeism in nurses ( P<0.001) . Conclusions:ICU nurses are at a high level of presenteeism, and total scores on the Nurse Resilience-related Practice Environment Factor Assessment Scale are negatively correlated with presenteeism. Nursing administrators should emphasize the psychological state of ICU nurses and improve the resilience-related practice environment in ICUs, thereby reducing the incidence of presenteeism among ICU nurses.

Objective To observe the application value of ultrasound classification of blood vessels at C6 transverse process region during ultrasound-guided cervical sympathetic block(CSB).Methods A total of 42 pain patients were retrospectively enrolled.According to vascular distribution morphology and variation,as well as the minimum vertical distance from carotid artery to C6 transverse process shown by ultrasound,blood vessels at C6 transverse process region was classified into type Ⅰ(standard type),Ⅱ(short arterial spacing type),Ⅲ(puncture path obstruction type)and Ⅳ(vascular variation type in blockade zone).CSB needle insertion strategy was adjusted according to the results of ultrasound classification.The needle tip directly reached the puncture target for type Ⅰ,"fluid push method"was used for type Ⅱ and type Ⅲ,while the needle tip needed to be guided to reach the area between carotid sheath and variant blood vessels in the puncture target area for type Ⅳ.The effectiveness and safety of this method were observed.Results Among 42 cases,type Ⅰ was observed in 18 cases(18/42,42.86%),type Ⅱ was noticed in 3 cases(3/42,7.14%),and type Ⅲ and Ⅳ was detected in 9(9/42,21.43%)and 12(12/42,28.57%)cases,respectively.CSB was successfully performed in all 42 cases,Horner syndrome was successfully induced and relieved spontaneously within 1-2 h.No adverse reactions such as local hematoma,pneumothorax,nor local pain was observed.Conclusion Ultrasound classification of blood vessels at C6 transverse process region during CSB was effective and safe,having certain promotion value.

Objective To explore the characteristics of fluid flow within loaded osteons under different boundary conditions.Methods The COMSOL Multiphysics software was used to establish a three-dimensional(3D)finite element model of osteons with different boundary conditions,and the variation rules of pore pressure and flow velocity of osteons under different inner wall pulsating blood pressures and outer wall elastic constraint conditions were analyzed.Results As the pulsatile blood pressure inside the osteon increased from 0 mmHg(1 mmHg=0.133 kPa)to 300 mmHg,the peak pore pressure within the osteon correspondingly increased from 26 kPa to 68 kPa.As the elastic constraint on the outer wall of osteons changed from being completely elastic to completely constrained,the peak pore pressure within osteons increased from 15 kPa to 26 kPa,and the peak flow velocity increased from 0.04 um/s to 0.07 um/s.Conclusions This study reveals the influence laws of changes in boundary conditions such as the pulsatile blood pressure on the inner wall and the elastic constraint on the outer wall of osteons on fluid flow characteristics within loaded osteons.These findings are conducive to a deeper understanding of the mechanical response mechanisms of bone tissues in both physiological and pathological states,and provide an important theoretical basrs for further researches on bone mechanotransduction.